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University of Nebraska Medical Center

The research and development landscape for mpox vaccines

The Lancet On Aug 14, 2024, WHO redeclared the mpox outbreak as a public health emergency of international concern (PHEIC). In contrast to the 2022 PHEIC, which was related to the global outbreak of mpox caused by the clade IIb strain, the 2024 PHEIC, attributed to the clade Ib strain, is primarily spreading through human contact in Africa, with a substantial number of cases occurring among children and a higher case fatality rate.1 As effective therapeutic drugs for mpox remain unavailable, research and development (R&D) for mpox vaccines are crucial to preventing further spread, including both local and international transmission in the African region.

Here, we collected data on the pipelines of prophylactic vaccine candidates for mpox globally from the Pharmcube database. This database is commonly used to provide an overview of vaccine R&D due to its comprehensive collection of authoritative information on drugs, clinical trials, and literature.2 As of Nov 7, 2024, after excluding three vaccines against mpox (LC16m8, ACAM2000, and MVA-BN) that have received marketing authorisation, the global vaccine R&D platform includes 20 candidates (table). Nucleic acid vaccine platforms, which include RNA and DNA vaccines, constitute the largest segment of the overall pipeline, accounting for 65% (13 of 20) of candidates. However, only three mRNA vaccines (mRNA-1769, BNT166a, and BNT166c) have progressed to the clinical phase. The attenuated vaccine platforms now represent the second largest segment of the overall pipeline, comprising 20% (four of 20) of candidates. The most frequently used virus in R&D is the monkeypox virus (14 candidates). Mpox vaccine R&D is primarily concentrated in China (nine candidates) and the USA (four candidates), largely due to their robust R&D capabilities and supportive regulatory policies. A substantial majority (65%; 13 of 20) of candidates are being developed by private companies and industry.

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